Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain

Post-mastectomy Pain Syndrome Clinical Trial

Official title:

Pain Relieving Potentials of Preoperative Combination of Single Dose Oral Duloxetine and Intravenous Magnesium Sulphate in Acute and Chronic Post Mastectomy Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087211
• Other study ID #: AP2307-301-002
• Status: Recruiting
• Phase: Phase 4
• Start date: October 10, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: National Cancer Institute, Egypt
• Contact: Norma Osama AbdAlla Zayed, MD
• Phone: 01067843111
• Email: normazayed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.

The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.

Description:

It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical I-II

• Scheduled for MRM

• Under general anesthesia.

Exclusion Criteria:

• Liver or kidney disease

• Patient with previous chronic pain on opioids

• Patients on antidepressants and antipsychotics.

• Allergies to study drugs

Related Conditions & MeSH terms

• Post-mastectomy Pain Syndrome

Intervention

Drug:
• Duloxetine and magnesium sulphate
this group will receive Duloxetine 30 mg orally and an intravenous (IV) infusion of magnesium sulphate 50mg/kg mixed with 200ml normal saline (NS) 1 hour before surgery
• Duloxetine
this group will receive Duloxetine 30 mg orally and 200ml NS infusion 1 hour before surgery
• placebo
will receive placebo capsule and an IV infusion of 200ml NS 1 hour before surgery

Locations

Country	Name	City	State
Egypt	National cancer institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic request	time to first dose of rescue analgesia	24 hours after surgery
Secondary	Postoperative morphine consumption	amount of morphine consumed (mg)	24 hours after surgery
Secondary	visual analogue scale score	assessment of postoperative pain using the visual analogue scale score. the scale is a straight horizontal line (100 mm). The ends are defined as the extreme limits of pain orientated from the left (no pain) to the right (worst pain).The patient marks on the line the point that they feel represents their perception of their current state.; The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.higher VAS score means worse pain	at 2 hour,6 hour, 12 hour and 24 hour
Secondary	incidence of post mastectomy pain syndrome	incidence of post mastectomy pain syndrome	at 8 weeks postoperative and 12 weeks postoperative